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NCT00101764 · ClinicalTrials.gov registry record · Phase 1
Intravitreal v. Sub-tenon Injections of Triamcinolone Acetonide for Macular Edema in Retinal Disorders
A Phase 1 study of Diabetic Retinopathy and Macular Degeneration, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT00101764: Completed Phase 1 study of Diabetic Retinopathy and Macular Degeneration, sponsored by National Eye Institute (NEI).
NCT00101764 is a Phase 1 study of Diabetic Retinopathy and Macular Degeneration that has completed, run by National Eye Institute (NEI). The registered enrollment target is 120 participants, below the 1,674-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00101764, a Phase 1 study of Diabetic Retinopathy and Macular Degeneration, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The use of intravitreal injections of corticosteroid (triamcinolone acetonide) appears to be a promising treatment for a variety of ocular diseases associated with inflammation. To date, the only drug available, "Kenalog-40 Injection" produced by Bristol Myers Squibb, has not been formulated for intraocular use. The purpose of this study is to evaluate the long-term safety and potential efficacy of novel intravitreal injections of a preservative-free formulation of triamcinolone acetonide (TAC-PF) at two dosage levels (4 mg and 8 mg) compared to anterior sub-tenon injections of TAC-PF at 20 mg. The study will be a masked, randomized Phase I study that will enroll 120 participants with one of the following diseases: age-related macular degeneration (AMD), diabetic macular edema (DME), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), or any other retinal disease with associated macular edema. At least 21 participants will be enrolled in the four designated disease strata: AMD, DME, CRVO, and BRVO. The remaining 36 participants may have one of these diseases or may be enrolled with another retinal disease. Within each disease strata, at least seven participants will be randomized to each dosing group. The participants will be randomly assigned to one of the three treatment groups. The primary outcome will be an assessment of post-injection intraocular toxicity-related events during the 3-year follow-up, including cataract formation, development of glaucoma, and any adverse event preventing retreatment. The secondary outcomes will be an improvement in best-corrected visual acuity (BCVA, EVA) and decreases in retinal thickening and area of leakage, from baseline to year 1.
Conditions Studied
Interventions
- DRUG Triamcinolone Acetonide
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2005-01-05 |
| Est. Completion | 2008-05-20 |
| Phase | Phase 1 |
What the finished NCT00101764 record still lists
NCT00101764 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,674-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Diabetic Retinopathy appearing as the primary indexed condition, and to 1 intervention - of which Triamcinolone Acetonide is the first listed.
NCT00101764 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00101764 about?
NCT00101764 is a clinical study titled "Intravitreal v. Sub-tenon Injections of Triamcinolone Acetonide for Macular Edema in Retinal Disorders". The use of intravitreal injections of corticosteroid (triamcinolone acetonide) appears to be a promising treatment for a variety of ocular diseases associated with inflammation. To date, the only drug available, "Kenalog-40 Injection" produced by Bristol Myers Squibb, has not been formulated for int...
What is the current status of trial NCT00101764?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2005-01-05. Estimated completion is 2008-05-20.
What conditions does trial NCT00101764 study?
This clinical trial studies the following conditions: Diabetic Retinopathy, Macular Degeneration, Retinal Vein Occlusion.
What interventions are being tested in trial NCT00101764?
The interventions under investigation include: Triamcinolone Acetonide (DRUG).
Who is sponsoring clinical trial NCT00101764?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00101764 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00101764's enrollment target sits among peer trials
120 36th of 57 higher than 22 of 57 other Diabetic Retinopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Retinopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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